FDA Approves Xeomin (IncobotulinumtoxinA)

Subject: FDA Approves Xeomin (IncobotulinumtoxinA)

Date: 8/10/2010

The United States Food and Drug Administration has approved Xeomin (incobotulinumtoxinA) for treatment of cervical dystonia and blepharospasm. Xeomin, manufactured by Merz Pharmaceuticals, is a formulation of BoNT/A without the complexing proteins found in other commercial preparations of BoNT/A.

According to the prescribing information available on the FDA website ( www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory#apphist ), Xeomin is indicated for:

--Adults with cervical dystonia, to decrease the severity of abnormal head position and neck pain in both botulinum toxin-naïve and previously treated patients.
--Blepharospasm in adults previously treated with onabotulinumtoxinA (Botox®).

An E-MOVE report on the pivotal clinical trials leading to approval is archived at www.mdvu.org/emove/article.asp?ID=1170